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FDA 510(k)

GIP/MEDI-GLOBE NEEDLE SYSTEM FOR ULTRASONIC FNA

K-Number: K935844 · 1995-02-13

ApplicantMedi-Globe Corp.
Decision Date1995-02-13
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GIP/MEDI-GLOBE NEEDLE SYSTEM FOR ULTRASONIC FNA is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Globe Corp.. It received FDA 510(k) clearance on 1995-02-13 under 510(k) number K935844. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GIP/MEDI-GLOBE NEEDLE SYSTEM FOR ULTRASONIC FNA?

GIP/MEDI-GLOBE NEEDLE SYSTEM FOR ULTRASONIC FNA is a medical device that received FDA 510(k) clearance on 1995-02-13. The listed applicant is Medi-Globe Corp.. The 510(k) number is K935844.

When did GIP/MEDI-GLOBE NEEDLE SYSTEM FOR ULTRASONIC FNA receive FDA 510(k) clearance?

GIP/MEDI-GLOBE NEEDLE SYSTEM FOR ULTRASONIC FNA received FDA 510(k) clearance on 1995-02-13, under 510(k) number K935844.

Who is the listed applicant for GIP/MEDI-GLOBE NEEDLE SYSTEM FOR ULTRASONIC FNA?

The FDA 510(k) record lists Medi-Globe Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GIP/MEDI-GLOBE NEEDLE SYSTEM FOR ULTRASONIC FNA?

The FDA product code for GIP/MEDI-GLOBE NEEDLE SYSTEM FOR ULTRASONIC FNA is FCG.

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Other records listing Medi-Globe Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K061222INJECTRA INJECTION NEEDLEK051247SONOTIP II ULTRASOUND NEEDLE SYSTEMK011261STONE EXTRACTOR BALLOON CATHETERK010714EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830K010549BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS)K990220MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM

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Related Devices (Code: FCG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252646Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)Olympus Medical Systems Corp.K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.K231422Precision GILimaca Medical, Ltd.K231267ClearTipFinemedix Co., Ltd.K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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